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Wallström, Commission. - In June 2001 the Commission adopted a follow-up communication to the Council and European Parliament on the implementation of the Community strategy for endocrine disrupters - that is, hormone-disturbing substances. This communication set out the actions that would be undertaken to address the potential environmental and health impacts of endocrine disruption, in line with the Commission's obligation to protect the health of the people and the environment within the European Union.

In this context, the availability of agreed test strategies and methods to identify and assess endocrine-disrupting chemicals is a basic requirement for comprehensive legislative action.

The Commission participates in the OECD Endocrine Disrupters Testing and Assessment Task Force (EDTA) which was set up in 1998. The main duties of this task force are to develop an internationally harmonised testing strategy and to coordinate and oversee the work of different sub-groups charged with developing new test guidelines, or revise existing ones to assess the potential endocrine-disrupting properties of chemicals.

The task force has reached a consensus on the development of a conceptual framework. This will provide the opportunity for sorting and prioritisation of chemicals of concern based upon existing information rather than on new data to be generated as part of the assessment process. This framework generates information on mechanistic data in vitro, in vivo, and/or on other adverse effects from endocrine and other mechanisms.

In addition the task force has defined a set of methods to be developed and validated: a comparison of sensitivity, relevance and reliability of the tests for testing the effects of endocrine disrupters on human health and/or the environment.

The latest estimates are that agreed test methods for some environmental effects are expected from this year to 2005 while some test methods relevant for human health risk assessment are expected to be finalised between this year and 2004. New validated and agreed tests for endocrine disruption will help a clearer identification of endocrine disrupters and allow informed judgements to be made on the likelihood of adverse effect manifestations.

As part of the Community strategy for endocrine disrupters the Commission launched a dedicated call for research proposals in 2001. A total of EUR 20 million was allocated to this initiative and, together with further funding under the Fifth European Research and Development Framework Programme, approximately EUR 59 million is currently being spent on research into the potential impact of endocrine-disrupting chemicals on human health and the environment. This research includes the development of novel testing methods.

It is important to recognise that endocrine disruption is not a toxicological end point per se, as is cancer or allergy, but that it is a mechanism of action that may lead to adverse toxic effects. By the nature of their effects most of the endocrine disrupters would normally qualify as CMRs - carcinogenic, mutagenic or toxic to reproduction. Such chemicals will have to undergo authorisation under the REACH system foreseen in the White Paper on the Future Chemicals Policy.

Furthermore, adverse affects on the endocrine system of wildlife species have been causally linked to certain persistent biocumulative and toxic substances which will also be subject to authorisation.

The Commission is currently considering whether to include in the draft proposal for the REACH regulation a provision to the effect that substances characterised as persistent biocumulative and toxic, or very persistent and very biocumulative - and, on a case-by-case basis, those substances of equivalent level of concern, such as endocrine disrupters not already caught by the CMR criteria - should be subject to authorisation.

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